2022-05065. Buprofezin; Pesticide Tolerances  

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    AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes tolerances for residues of buprofezin in or on multiple commodities which are identified and discussed later in this document. The Interregional Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

    DATES:

    This regulation is effective March 10, 2022. Objections and requests for hearings must be received on or before May 9, 2022, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ).

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2020-0235, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room and for the OPP Docket is (202) 566-1744.

    Due to the public emergency, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https://www.epa.gov/​dockets.

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    FOR FURTHER INFORMATION CONTACT:

    Marietta Echeverria, Acting Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: RDFRNotices@epa.gov.

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    SUPPLEMENTARY INFORMATION:

    I. General Information

    A. Does this action apply to me?

    You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

    • Crop production (NAICS code 111).
    • Animal production (NAICS code 112).
    • Food manufacturing (NAICS code 311).
    • Pesticide manufacturing (NAICS code 32532).

    B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Office of the Federal Register's e-CFR site at https://www.ecfr.gov.

    C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2020-0235 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before May 9, 2022. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

    In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2020-0235, by one of the following methods:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

    Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

    Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https://www.epa.gov/​dockets/​where-send-comments-epa-dockets.

    Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/​dockets.

    II. Summary of Petitioned-For Tolerance

    In the Federal Registers of June 24, 2020 (85 FR 37806) (FRL-10010-82), and August 5, 2020 (85 FR 47330) (FRL-10012-32), EPA issued documents pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0E8828) by IR-4, North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. These petitions requested that 40 CFR 180.511 be amended by establishing tolerances for residues of the insecticide buprofezin, 2-[(1,1 dimethylethyl)imino]tetrahydro-3(1-methylethyl)-5-phenyl-4 H -1,3,5-thiadiazin-4-one, in or on asparagus bean, edible podded at 0.02 parts per million (ppm); bushberry subgroup 13-07B at 0.08 ppm; catjang bean, edible podded at 0.02 ppm; Chinese longbean, edible podded at 0.02 ppm; cowpea, edible podded at 0.02 ppm; french bean, edible podded at 0.02 ppm; garden bean, edible podded at 0.02 ppm; green bean, edible podded at 0.02 ppm; goa bean, edible podded at 0.02 ppm; guar Start Printed Page 13641 bean, edible podded at 0.02 ppm; jackbean, edible podded at 0.02 ppm; kidney bean, edible podded at 0.02 ppm; lablab bean, edible podded at 0.02 ppm; moth bean, edible podded at 0.02 ppm; mung bean, edible podded at 0.02 ppm; navy bean, edible podded at 0.02 ppm; rice bean, edible podded at 0.02 ppm; scarlet runner bean, edible podded at 0.02 ppm; snap bean, edible podded at 0.02 ppm; sword bean, edible podded at 0.02 ppm; urd bean, edible podded at 0.02 ppm; vegetable soybean, edible podded at 0.02 ppm; velvet bean, edible podded at 0.02 ppm; wax bean, edible podded at 0.02 ppm; winged pea, edible podded at 0.02 ppm; and yardlong bean, edible podded at 0.02 ppm.

    In addition, IR-4 proposed, upon the approval of the aforementioned tolerances, to remove the established tolerance for the residues of buprofezin, including its metabolites and degradates in or on bean, snap, succulent at 0.02 ppm.

    Three comments were received on the notices of filings. EPA's responses to these comments are discussed in Unit IV.C.

    III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

    Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for buprofezin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with buprofezin follows.

    In an effort to streamline its publications in the Federal Register , EPA is not reprinting sections of the rule that would repeat what has been previously published in tolerance rulemakings for the same pesticide chemical. Where scientific information concerning a particular pesticide chemical remains unchanged, the content of those sections would not vary between tolerance rulemakings and republishing the same sections is unnecessary and duplicative. EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination for the new rulemaking.

    EPA has previously published a number of tolerance rulemakings for buprofezin, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to buprofezin and established tolerances for residues of that chemical. EPA is incorporating previously published sections from those rulemakings as described further in this rulemaking, as they remain unchanged.

    Toxicological profile. For a discussion of the Toxicological Profile of buprofezin and aniline, a substance that may be formed as a degradate in food from buprofezin and its aniline-containing metabolites as a result of cooking, see Unit III.A. of the August 29, 2019 rulemaking (84 FR 45426) (FRL-9997-41). There is, however, a new discussion of the non-cancer toxicity characterization of aniline in Appendix F of the document titled “Buprofezin. Human Health Risk Assessment for Proposed New Use on Bushberry Crop Subgroup 13-07B and Proposed Amendments to Expand Use on Succulent Beans to All Members of Proposed Edible Podded Bean Legume Vegetable Subgroup 6-XXA and Use on Greenhouse-Grown Tomatoes and Peppers to All Members of Fruiting Vegetable Crop Group 8-10” (hereinafter “Buprofezin Human Health Risk Assessment.”)

    Toxicological points of departure/Levels of concern. For a summary of the Toxicological Points of Departure/Levels of Concern used for the risk assessment, see Unit III.B. of the August 29, 2019 rulemaking.

    Exposure assessment. Much of the exposure assessment remains the same, although the dietary exposure and risk assessments for buprofezin and buprofezin-derived aniline were updated. These updates are discussed in this section; for a description of the rest of EPA's approach to and assumptions for the exposure assessment, see Unit III.C. of the August 29, 2019 rulemaking.

    EPA's dietary exposure assessments have been updated to include the additional exposures for the new uses of buprofezin. The assessment used the same assumptions as the August 29, 2019 final rule concerning tolerance level residues, default and empirical processing factors for all processed commodities assumptions, and a conservative factor to account for the presence of the BF4 Conjugate (2-(2-hydroxy-1,1-dimethylethylimino)-3-isopropyl-5-phenyl-1,3,5-thiadiazinan-4-one). The acute dietary exposure assessment assumed 100 percent crop treated (PCT).

    Updated PCT estimates were used in the chronic dietary risk assessment for crops that are currently registered for buprofezin: Almond 1%, apple 2.5%, apricot 5%, broccoli 2.5%, cabbage 2.5%, cantaloupe 15%, cauliflower 5%, celery 1%, cherry 10%, cotton 1%, cucumber 1%, grapefruit 5%, raisin grape 5%, table grape 10%, wine grape 2.5%, honeydew 75%, lemon 2.5%, lettuce 10%, nectarine 15%, olive 1%, orange 2.5%, peach 5%, pear 15%, pepper 1%, pistachio 15%, plum/prune 2.5%, pumpkin 1%, spinach 1%, squash 2.5%, strawberry 15%, tangerine 10%, tomato 1%, walnut 2.5%, and watermelon 1%. These average PCT data were also used to refine the cancer dietary exposure analysis for buprofezin-derived aniline. All other crops assumed 100% crop treated.

    A cancer dietary exposure risk assessment for buprofezin was not conducted because the only evidence of carcinogenicity was for benign liver tumors in one sex (males) and one species (mouse); there was no evidence of carcinogenicity in rats of either sex or in female mice. An updated, highly refined cancer dietary exposure (cooked food forms only) and risk assessment for buprofezin-derived aniline residues, including those derived from aniline-containing metabolites of buprofezin, was conducted. This assessment was conducted using (1) buprofezin monitoring data for raw/uncooked agricultural commodities (RACs) provided by the United States Department of Agriculture Pesticide Data Program (PDP) to estimate average residues of buprofezin; (2) buprofezin field trial data; (3) empirical and EPA's 2018 default processing factors; (4) average buprofezin PCT data; and (5) the maximum conversion factor for buprofezin-derived aniline of 18.9%. The conversion factor of 18.9%, the highest found in a previously submitted hydrolysis study, was applied to Start Printed Page 13642 estimate residues of buprofezin-derived aniline which may form in food as a result of cooking. The highly refined estimated exposure of the highest exposed adult population (adults 50 to 99 years old) to buprofezin-derived aniline results in an upper bound cancer risk estimate of 3 × 10−7 .

    Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

    Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:

    Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.

    Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.

    Condition c: Data are available on pesticide use and food consumption in a particular area, and the exposure estimate does not understate exposure for the population in such area.

    In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

    In most cases, EPA uses available data from the United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the California Department of Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the chemical/crop combination for the most recent 10 years. EPA uses an average PCT for chronic dietary risk analysis and a maximum PCT for acute dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding up to the nearest 5%, except for those situations in which the average PCT is less than 1% or less than 2.5%. In those cases, the Agency would use less than 1% or less than 2.5% as the average PCT value, respectively. The maximum PCT figure is the highest observed maximum value reported within the most recent 10 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%, except where the maximum PCT is less than 2.5%, in which case, the Agency uses less than 2.5% as the maximum PCT.

    The Agency believes that Conditions a, b, and c discussed above have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which buprofezin may be applied in a particular area.

    Drinking water, non-occupational, and cumulative exposures. Drinking water and non-occupational exposures are not impacted by the new uses, and thus have not changed since the last assessment. EPA's conclusions concerning cumulative risk remain unchanged from Unit III.C.2. of the August 29, 2019 rulemaking.

    Safety factor for infants and children. EPA continues to conclude that a 10X FQPA SF must be retained for repeated exposure scenarios because those assessments are based on a study that did not show a No Observed Adverse Effect Level (NOAEL). EPA also continues to conclude that there is reliable data showing that the safety of infants and children would be adequately protected if the FQPA SF were reduced from 10X to 1X for single exposures. The reasons for these decisions are articulated in Unit III.D. of the August 29, 2019 rulemaking.

    Aggregate risks and determination of safety. EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing dietary exposure estimates to the acute population adjusted dose (aPAD) and the chronic population adjusted dose (cPAD). Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate points of departure to ensure that an adequate margin of exposure (MOE) exists. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure.

    Acute dietary risks are below the Agency's level of concern of 100% of the aPAD; they are 5.8% of the aPAD for females 13-49 years old, which is the only population subgroup with an acute dietary endpoint. Chronic dietary risks are below the Agency's level of concern of 100% of the cPAD; they are 42% of the cPAD for children 1 to 2 years old, the most highly exposed subpopulation. Buprofezin is classified as “Suggestive Evidence of Carcinogenicity, but not sufficient to assess human carcinogenic potential.” EPA has determined that the quantification of risk using a non-linear ( i.e., reference dose) approach will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to buprofezin. Because the chronic dietary risks are below the Agency's level of concern, buprofezin is not expected to pose a cancer risk to humans.

    There are no data to determine an acute endpoint for aniline at this time; hence, an acute dietary risk assessment was not conducted for buprofezin-derived aniline. The highly refined estimated chronic exposure of the most highly exposed adult subpopulation (adults 50 to 99 years old) to buprofezin-derived aniline is 0.000052 mg/kg/day. Estimated chronic exposures to buprofezin-derived aniline are orders of magnitude below any potential chronic non-cancer reference dose for aniline. Therefore, a quantitative chronic non-cancer dietary risk assessment for buprofezin-derived aniline is not necessary to conclude with reasonable certainty that chronic exposures from buprofezin-derived aniline do not pose a non-cancer dietary risk. The highly refined estimated chronic exposure of the most highly exposed adult subpopulation results in an upper bound cancer risk estimate of 3 × 10−7, Start Printed Page 13643 which is below the Agency's level of concern of 1 × 10−6 .

    There are no residential uses of buprofezin; therefore, the aggregate risk assessment is equivalent to the acute and chronic dietary (food and drinking water) exposure and risk assessments to buprofezin and buprofezin-derived aniline and are not of concern.

    Therefore, based on the risk assessments and information described above, EPA concludes there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to buprofezin residues. More detailed information about the Agency's analysis can be found at https://www.regulations.gov in the document “Buprofezin Human Health Risk Assessment” in docket ID number EPA-HQ-OPP-2020-0235.

    IV. Other Considerations

    A. Analytical Enforcement Methodology

    Adequate enforcement methods are available in Pesticide Analytical Manual Volume I (PAM I) and PAM II for enforcement of buprofezin tolerances, including gas chromatography methods with nitrogen phosphorus detection (GC/NPD), and a GC/mass spectrometry (GC/MS) method for confirmation of buprofezin residues in plant and livestock commodities. The GC/MS method used for plant commodities utilizes three ions for identification of buprofezin. The validated limit of quantitation (LOQ) was 0.05 ppm. In addition, method BF/10/97 is an adequate enforcement method for enforcement of buprofezin tolerances in/on bean commodities. The LOQ is 0.02 ppm.

    B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4).

    No Codex MRLs have been established for residues of buprofezin in/on the proposed commodities in this action.

    C. Response to Comments

    Although three comments were submitted to the docket in response to the June 24, 2020, and August 5, 2020 notifications of filings, only one specifically related to this tolerance action. This comment was from a representative from the Republic of Ecuador. The commenter's concern was that the proposed U.S. MRLs for buprofezin on beans at 0.02 ppm would prevent beans from Ecuador from being imported and marketed in the U.S. because of buprofezin residues higher than 0.02 ppm. The commenter was also concerned that the U.S. would reduce the tolerance for residues in/on beans to be more restrictive. The commenter also stated that it is essential for pesticide tolerances to be based on scientific evidence, conclusive data and not under the precautionary principle.

    The existing tolerance for residues in/on bean, snap, succulent is based on previously submitted and reviewed field trial residue data that demonstrate that residues of buprofezin in/on snap beans are less than the limit of quantitation, which is 0.02 ppm. The petitioner requested, and EPA agrees that it is appropriate, to extrapolate the field trial data on succulent snap beans to support tolerances for residues in/on the 25 specific edible podded bean commodities. Therefore, this action is based on scientific evidence and conclusive data and actually increases the tolerances for most of the edible podded bean commodities from zero (not existent) to 0.02 ppm. Ecuador has adopted the established European Union (EU) MRL of 0.01 ppm for residues of buprofezin in/on beans (with pods) and beans (without pods). The recommended U.S. tolerance of 0.02 ppm for residues of buprofezin in/on individual edible podded bean commodities is not more restrictive than this MRL. The U.S. tolerances are based on the use pattern that is registered in the U.S. If the use pattern is different in Ecuador, the bean growers or another organization could submit a petition for an import tolerance for residues of buprofezin in/on beans, with supporting field trial residue data based on the alternate use pattern. EPA would review such a petition to determine if it meets the statutory standard that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to buprofezin residues.

    D. Revisions to Petitioned-For Tolerances

    Most of the proposed commodity definitions have been modified to be consistent with Agency nomenclature.

    V. Conclusion

    Therefore, tolerances are established for residues of buprofezin, 2-[(1,1-dimethylethyl)imino]tetrahydro-3-(1-methylethyl)-5-phenyl-4 H -1,3,5-thiadiazin-4-one, in or on Bean, asparagus, edible podded at 0.02 ppm; Bean, catjang, edible podded at 0.02 ppm; Bean, french, edible podded at 0.02 ppm; Bean, garden, edible podded at 0.02 ppm; Bean, goa, edible podded at 0.02 ppm; Bean, green, edible podded at 0.02 ppm; Bean, guar, edible podded at 0.02 ppm; Bean, kidney, edible podded at 0.02 ppm; Bean, lablab, edible podded at 0.02 ppm; Bean, moth, edible podded at 0.02 ppm; Bean, mung, edible podded at 0.02 ppm; Bean, navy, edible podded at 0.02 ppm; Bean, rice, edible podded at 0.02 ppm; Bean, scarlet runner, edible podded at 0.02 ppm; Bean, snap, edible podded at 0.02 ppm; Bean, sword, edible podded at 0.02 ppm; Bean, urd, edible podded at 0.02 ppm; Bean, wax, edible podded at 0.02 ppm; Bean, yardlong, edible podded at 0.02 ppm; Bushberry subgroup 13-07B at 0.08 ppm; Cowpea, edible podded at 0.02 ppm; Jackbean, edible podded at 0.02 ppm; Longbean, chinese, edible podded at 0.02 ppm; Pea, winged, edible podded at 0.02 ppm; Soybean, vegetable, edible podded at 0.02 ppm; and Velvetbean, edible podded at 0.02 ppm.

    Upon establishment of the aforementioned tolerances, the established tolerance for the residues of buprofezin, including its metabolites and degradates in or on Bean, snap, succulent at 0.02 ppm will be removed, as it is superseded by the new tolerances on the edible podded bean commodities. In addition, EPA is revising the tolerance expression in paragraph (a) to correct the chemical name of buprofezin.

    VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in response to petitions submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), nor does it require any special considerations under Start Printed Page 13644 Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

    Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), do not apply.

    This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal Governments, on the relationship between the National Government and the States or Tribal Governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq. ).

    This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

    VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

    Start List of Subjects

    List of Subjects in 40 CFR Part 180

    • Environmental protection
    • Administrative practice and procedure
    • Agricultural commodities
    • Pesticides and pests
    • Reporting and recordkeeping requirements
    End List of Subjects Start Signature

    Dated: March 4, 2022.

    Marietta Echeverria,

    Acting Director, Registration Division, Office of Pesticide Programs.

    End Signature

    Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows:

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    PART 180—TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD

    End Part Start Amendment Part

    1. The authority citation for part 180 continues to read as follows:

    End Amendment Part Start Authority

    Authority: 21 U.S.C. 321(q), 346a and 371.

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    2. In § 180.511, amend paragraph (a) by:

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    a. Revising the introductory text.

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    b. Adding in alphabetical order to the table the entries “Bean, asparagus, edible podded”; “Bean, catjang, edible podded”; “Bean, french, edible podded”; “Bean, garden, edible podded”; “Bean, goa, edible podded”; “Bean, green, edible podded”; “Bean, guar, edible podded”; “Bean, kidney, edible podded”; “Bean, lablab, edible podded”; “Bean, moth, edible podded”; “Bean, mung, edible podded”; “Bean, navy, edible podded”; “Bean, rice, edible podded”; “Bean, scarlet runner, edible podded”; and “Bean, snap, edible podded”.

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    c. Removing the entry from the table for “Bean, snap, succulent”.

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    d. Adding in alphabetical order to the table the entries “Bean, sword, edible podded”; “Bean, urd, edible podded”; “Bean, wax, edible podded”; “Bean, yardlong, edible podded”; “Bushberry subgroup 13-07B”; “Cowpea, edible podded”; “Jackbean, edible podded”; “Longbean, chinese, edible podded”; “Pea, winged, edible podded”; “Soybean, vegetable, edible podded”; and “Velvetbean, edible podded”.

    End Amendment Part

    The revision and additions read as follows:

    Buprofezin; tolerances for residues.

    (a) General. Tolerances are established for residues of buprofezin, including its metabolites and degradates in or on the commodities in the table in this paragraph (a). Compliance with the tolerance levels specified in the table in this paragraph (a) is to be determined by measuring only the buprofezin, 2-[(1,1-dimethylethyl)imino]tetrahydro-3-(1-methylethyl)-5-phenyl-4 H -1,3,5-thiadiazin-4-one, in the commodity.

    CommodityParts per million
    *    *    *    *    *
    Bean, asparagus, edible podded0.02
    Bean, catjang, edible podded0.02
    Bean, french, edible podded0.02
    Bean, garden, edible podded0.02
    Bean, goa, edible podded0.02
    Bean, green, edible podded0.02
    Bean, guar, edible podded0.02
    Bean, kidney, edible podded0.02
    Bean, lablab, edible podded0.02
    Bean, moth, edible podded0.02
    Bean, mung, edible podded0.02
    Bean, navy, edible podded0.02
    Bean, rice, edible podded0.02
    Bean, scarlet runner, edible podded0.02
    Bean, snap, edible podded0.02
    *    *    *    *    *
    Bean, sword, edible podded0.02
    Bean, urd, edible podded0.02
    Bean, wax, edible podded0.02
    Bean, yardlong, edible podded0.02
    *    *    *    *    *
    Bushberry subgroup 13-07B0.08
    *    *    *    *    *
    Cowpea, edible podded0.02
    *    *    *    *    *
    Jackbean, edible podded0.02
    *    *    *    *    *
    Longbean, chinese, edible podded0.02
    *    *    *    *    *
    Pea, winged, edible podded0.02
    *    *    *    *    *
    Soybean, vegetable, edible podded0.02
    *    *    *    *    *
    Velvetbean, edible podded0.02
    * * * * *
    End Supplemental Information

    [FR Doc. 2022-05065 Filed 3-9-22; 8:45 am]

    BILLING CODE 6560-50-P

Document Information

Effective Date:
3/10/2022
Published:
03/10/2022
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final rule.
Document Number:
2022-05065
Dates:
This regulation is effective March 10, 2022. Objections and requests for hearings must be received on or before May 9, 2022, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
Pages:
13640-13644 (5 pages)
Docket Numbers:
EPA-HQ-OPP-2020-0235, FRL-9067-01-OCSPP
Topics:
Administrative practice and procedure, Agricultural commodities, Environmental protection, Pesticides and pests, Reporting and recordkeeping requirements
PDF File:
2022-05065.pdf
Supporting Documents:
» Buprofezin. Occupational and Residential Exposure Assessment for Proposed New Use on Bushbeny Subgroup 13-07B, Except Bluebeny , Lowbush; Lingonbeny; and Goosebeny ; and Crop Group Expansions for Individual Commodities in the Proposed Edible Podded Bean Legume Vegetable Subgroup
» Buprofezin. Human Health Risk Assessment for Proposed New Use on Bushbeny Crop Subgroup 13-07B and Proposed Amendments to Expand Use on Succulent Beans to All Members of Proposed Edible Podded Bean Legume Vegetable Subgroup 6-XXA and Use on Greenhouse-Grown Tomatoes and Peppers to All Members ofFmiting Vegetable Crop Group 8-10
» Buprofezin: Acute, Chronic, (Food and Drinking Water) and Cancer (Aniline; Cooked Food Only) Aggregate Dietaiy Exposure and Risk Assessments for the New Use on Bushbeny Crop Subgroup 13-07B and Proposed Amendment to Expand the Use on Succulent Beans to All Members of Proposed Edible Podded
» Buprofezin: Petition for the Establishment of Permanent Tolerances and Registration for Use on Bushberry Crop Subgroup 13-07B and Proposed Amendments to Expand the Use on Succulent Beans to All Members of Proposed Edible Podded Bean Legume Vegetable Subgroup 6-XXA and Expand the Use on Greenhouse-Grown Tomatoes and Peppers to All Members of Vegetable, Fruiting, Group 8-10
» Pesticide Tolerance; Exemptions, Petitions, Revocations, etc.: Buprofezin
» Pesticide Petition Filed for Residues of Pesticide Chemicals in or on Various Commodities (June 2019)
» Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities (May 2020)
» Interregional Research Project No. 4 (IR-4) Notice of Filing Pesticide Petition No. 0E8828 by establishing tolerances for residues of [buprofezin, 2-[(1,1-dimethylethyl)imino]tetrahydro-3(1-methylethyl)-5-phenyl-4H-1,3,5-thiadiazin-4-one] in or on the raw agricultural commodities [Bushberry subgroup 13-07B] at [0.08] parts per million (ppm)
» Pesticide Product Registration; Applications: New Uses
CFR: (1)
40 CFR 180.511